Home GUDID 00742860100185 OSOM iFOB Control Kit
Primary DI 00742860100185
Brand OSOM iFOB Control Kit
Company Sekisui Diagnostics, LLC
Model 1000
Catalog number 1000
Device description OSOM iFOB Control Kit
Published 2017-01-10
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name OSL Control, fecal occult blood
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OSL Control, Fecal Occult Blood Hematology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00742860100185 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00742860100185 00742860100185 742860100185 0742860100185
GMDN Terms# Term, Definition table Term Definition Faecal occult blood IVD, control A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative screening of stool (faeces) for occult blood (haemoglobin and/or transferrin).
Regulatory Flags# DUNS number 966812344 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850093003033 InSure FIT ENTERIX INC. OSL 2016-09-20